Purpose of this Study
We are doing this study to compare two surgical procedures. We want to know if one procedure is better than the other in terms of lowering the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.
Who Can Participate?
Eligibility
Women ages 35-50 who:
- Have a positive test for BRCA1 mutations
- Have at least one intact ovary and one intact fallopian tube
Age Range
18-110
Sex/Genders
Female (cisgender)
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:
- Participants in Group 1 (BLS Group) will have surgery to remove the fallopian tubes and then have a second surgery later to remove the ovaries
- Participants in Group 2 (BSO Group) will have surgery to remove the fallopian tubes and ovaries at the same time
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
NRG-CC008, A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk] (NCT # 04251052)
Principal Investigator
Angeles
Secord
Protocol Number
PRO00111375
NCT ID
NCT04251052
Phase
N/A
Enrollment Status
Open to Enrollment